Background Improved measurement of clinically meaningful symptoms is needed in advanced bladder cancer.

Objective This study developed and examined the initial reliability and validity of a new measure of advanced bladder cancer specific symptoms, the NCCN-FACT Bladder Symptom Index-18 (NFBlSI-18), which assesses the symptoms perceived as most important by patients and oncology clinical experts.

Methods A total of 31 individuals with advanced bladder cancer rated the importance of 28 symptoms. In addition, 10 oncology clinical experts rated symptoms as treatment- or disease-related. Patient-rated symptoms were reconciled with published clinicians’ symptom priorities, producing the NFBlSI-18.  Participants completed measures of quality of life (QoL) and performance status to examine initial validity.

Results An 18-item symptom index for advanced bladder cancer included 3 subscales: disease-related symptoms, treatment side effects, and general function/well-being. Lower scores indicate greater symptom burden. Preliminary reliability reveals good internal consistency for the full NFBlSI-18 ( 0.83). The NFBlSI-18 was significantly associated with QOL criteria and performance status, in the expected direction.

Limitations Limitations include the cross-sectional design and the relatively low reliability of the disease-related symptoms subscale.

Conclusion The NFBlSI-18 demonstrates preliminary evidence as a valid brief measure of the most important symptoms of advanced bladder cancer, as rated by both patients and oncology clinical experts. The NFBlSI-18 should have greater acceptability to regulatory authorities than previously developed questionnaires.

*Click on the PDF icon at the top of this introduction to read the full article.

Background Improved measurement of clinically meaningful symptoms is needed in advanced bladder cancer.

Objective This study developed and examined the initial reliability and validity of a new measure of advanced bladder cancer specific symptoms, the NCCN-FACT Bladder Symptom Index-18 (NFBlSI-18), which assesses the symptoms perceived as most important by patients and oncology clinical experts.

Methods A total of 31 individuals with advanced bladder cancer rated the importance of 28 symptoms. In addition, 10 oncology clinical experts rated symptoms as treatment- or disease-related. Patient-rated symptoms were reconciled with published clinicians’ symptom priorities, producing the NFBlSI-18.  Participants completed measures of quality of life (QoL) and performance status to examine initial validity.

Results An 18-item symptom index for advanced bladder cancer included 3 subscales: disease-related symptoms, treatment side effects, and general function/well-being. Lower scores indicate greater symptom burden. Preliminary reliability reveals good internal consistency for the full NFBlSI-18 ( 0.83). The NFBlSI-18 was significantly associated with QOL criteria and performance status, in the expected direction.

Limitations Limitations include the cross-sectional design and the relatively low reliability of the disease-related symptoms subscale.

Conclusion The NFBlSI-18 demonstrates preliminary evidence as a valid brief measure of the most important symptoms of advanced bladder cancer, as rated by both patients and oncology clinical experts. The NFBlSI-18 should have greater acceptability to regulatory authorities than previously developed questionnaires.

*Click on the PDF icon at the top of this introduction to read the full article.

Background Improved measurement of clinically meaningful symptoms is needed in advanced bladder cancer.

Objective This study developed and examined the initial reliability and validity of a new measure of advanced bladder cancer specific symptoms, the NCCN-FACT Bladder Symptom Index-18 (NFBlSI-18), which assesses the symptoms perceived as most important by patients and oncology clinical experts.

Methods A total of 31 individuals with advanced bladder cancer rated the importance of 28 symptoms. In addition, 10 oncology clinical experts rated symptoms as treatment- or disease-related. Patient-rated symptoms were reconciled with published clinicians’ symptom priorities, producing the NFBlSI-18.  Participants completed measures of quality of life (QoL) and performance status to examine initial validity.

Results An 18-item symptom index for advanced bladder cancer included 3 subscales: disease-related symptoms, treatment side effects, and general function/well-being. Lower scores indicate greater symptom burden. Preliminary reliability reveals good internal consistency for the full NFBlSI-18 ( 0.83). The NFBlSI-18 was significantly associated with QOL criteria and performance status, in the expected direction.

Limitations Limitations include the cross-sectional design and the relatively low reliability of the disease-related symptoms subscale.

Conclusion The NFBlSI-18 demonstrates preliminary evidence as a valid brief measure of the most important symptoms of advanced bladder cancer, as rated by both patients and oncology clinical experts. The NFBlSI-18 should have greater acceptability to regulatory authorities than previously developed questionnaires.

*Click on the PDF icon at the top of this introduction to read the full article.

Recently, hospitalists around the country gathered together at Hospital Medicine 2013 to gain new and practical clinical insights we can use to optimize the medical care we provide to our patients, imbibe new research on the horizon, master clinical care guidelines, and sometimes, just relax and enjoy meeting new colleagues from around the country – naturally, comparing notes on how their practices stack up to our own. You could even pick up a book or two geared to hospitalists. I bought "Clinical Care Conundrums: Challenging Diagnoses in Hospital Medicine" and "Becoming a Consummate Clinician: What Every Student, House Office, and Hospital Practitioner Needs to Know." Learning just doesn’t get any better than this.

Information abounded, challenges were issued, and I think most of us learned how much we really need to learn more about. I believe we were thoroughly challenged to look at our current practice style, incorporate our new knowledge, and take our clinical acumen to the next level.

The first challenge began when I had to roll out of bed around 5 a.m. to prepare to make the hour-long drive down I-95 to the conference site at National Harbor, Md., to attend a 7:40 a.m. lecture: "Pain Management for the Hospitalist." I have not a single regret. It was well worth the bleary ride. I think many hospitalists share my concerns about overmedicating patients on the one hand, and being on guard for true drug seekers on the other.

My main takeaway was that when a patient is truly in pain, narcotic pain medication can be titrated up much more quickly than most of us currently feel comfortable with.

The lecture was presented by Dr. Eric Roeland of the University of Carolina, San Diego, who said that he sometimes doubles narcotic analgesics every 10 minutes under certain circumstances. Some participants were shocked (including me). He orders a dose of pain medication and then checks on the patient around the time of CMax (maximum concentration of the drug). For IV pain medications, this is approximately 10 minutes, for SC/IM it is 30 minutes, and for PO/PR it is 60 minutes. If his patient has not gotten pain relief by CMax, he orders twice the dose and checks back in again at the next CMax. If the patient still has no relief, Dr. Roeland will order four times the initial dose.

He stated that since sedation comes before respiratory depression, he feels comfortable increasing narcotics rapidly in patients who are "alert and playing Atari" or are otherwise highly functional. (I didn’t know Atari was still on the market.)

Click here for the presentation slides from this lecture and here for others.

Hope to see you next year when Hospital Medicine meets in Las Vegas!

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center, Glen Burnie, Md., who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a mobile app for iOS.

Recently, hospitalists around the country gathered together at Hospital Medicine 2013 to gain new and practical clinical insights we can use to optimize the medical care we provide to our patients, imbibe new research on the horizon, master clinical care guidelines, and sometimes, just relax and enjoy meeting new colleagues from around the country – naturally, comparing notes on how their practices stack up to our own. You could even pick up a book or two geared to hospitalists. I bought "Clinical Care Conundrums: Challenging Diagnoses in Hospital Medicine" and "Becoming a Consummate Clinician: What Every Student, House Office, and Hospital Practitioner Needs to Know." Learning just doesn’t get any better than this.

Information abounded, challenges were issued, and I think most of us learned how much we really need to learn more about. I believe we were thoroughly challenged to look at our current practice style, incorporate our new knowledge, and take our clinical acumen to the next level.

The first challenge began when I had to roll out of bed around 5 a.m. to prepare to make the hour-long drive down I-95 to the conference site at National Harbor, Md., to attend a 7:40 a.m. lecture: "Pain Management for the Hospitalist." I have not a single regret. It was well worth the bleary ride. I think many hospitalists share my concerns about overmedicating patients on the one hand, and being on guard for true drug seekers on the other.

My main takeaway was that when a patient is truly in pain, narcotic pain medication can be titrated up much more quickly than most of us currently feel comfortable with.

The lecture was presented by Dr. Eric Roeland of the University of Carolina, San Diego, who said that he sometimes doubles narcotic analgesics every 10 minutes under certain circumstances. Some participants were shocked (including me). He orders a dose of pain medication and then checks on the patient around the time of CMax (maximum concentration of the drug). For IV pain medications, this is approximately 10 minutes, for SC/IM it is 30 minutes, and for PO/PR it is 60 minutes. If his patient has not gotten pain relief by CMax, he orders twice the dose and checks back in again at the next CMax. If the patient still has no relief, Dr. Roeland will order four times the initial dose.

He stated that since sedation comes before respiratory depression, he feels comfortable increasing narcotics rapidly in patients who are "alert and playing Atari" or are otherwise highly functional. (I didn’t know Atari was still on the market.)

Click here for the presentation slides from this lecture and here for others.

Hope to see you next year when Hospital Medicine meets in Las Vegas!

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center, Glen Burnie, Md., who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a mobile app for iOS.

Recently, hospitalists around the country gathered together at Hospital Medicine 2013 to gain new and practical clinical insights we can use to optimize the medical care we provide to our patients, imbibe new research on the horizon, master clinical care guidelines, and sometimes, just relax and enjoy meeting new colleagues from around the country – naturally, comparing notes on how their practices stack up to our own. You could even pick up a book or two geared to hospitalists. I bought "Clinical Care Conundrums: Challenging Diagnoses in Hospital Medicine" and "Becoming a Consummate Clinician: What Every Student, House Office, and Hospital Practitioner Needs to Know." Learning just doesn’t get any better than this.

Information abounded, challenges were issued, and I think most of us learned how much we really need to learn more about. I believe we were thoroughly challenged to look at our current practice style, incorporate our new knowledge, and take our clinical acumen to the next level.

The first challenge began when I had to roll out of bed around 5 a.m. to prepare to make the hour-long drive down I-95 to the conference site at National Harbor, Md., to attend a 7:40 a.m. lecture: "Pain Management for the Hospitalist." I have not a single regret. It was well worth the bleary ride. I think many hospitalists share my concerns about overmedicating patients on the one hand, and being on guard for true drug seekers on the other.

My main takeaway was that when a patient is truly in pain, narcotic pain medication can be titrated up much more quickly than most of us currently feel comfortable with.

The lecture was presented by Dr. Eric Roeland of the University of Carolina, San Diego, who said that he sometimes doubles narcotic analgesics every 10 minutes under certain circumstances. Some participants were shocked (including me). He orders a dose of pain medication and then checks on the patient around the time of CMax (maximum concentration of the drug). For IV pain medications, this is approximately 10 minutes, for SC/IM it is 30 minutes, and for PO/PR it is 60 minutes. If his patient has not gotten pain relief by CMax, he orders twice the dose and checks back in again at the next CMax. If the patient still has no relief, Dr. Roeland will order four times the initial dose.

He stated that since sedation comes before respiratory depression, he feels comfortable increasing narcotics rapidly in patients who are "alert and playing Atari" or are otherwise highly functional. (I didn’t know Atari was still on the market.)

Click here for the presentation slides from this lecture and here for others.

Hope to see you next year when Hospital Medicine meets in Las Vegas!

Dr. Hester is a hospitalist with Baltimore-Washington Medical Center, Glen Burnie, Md., who has a passion for empowering patients to partner in their health care. She is the creator of the Patient Whiz, a mobile app for iOS.

WASHINGTON – Mandatory bicycle helmet laws are associated with a lower incidence of fatalities among youth cyclists involved in motor vehicle collisions, a national analysis has shown.

States with laws that require bicyclists to wear helmets had only 84% of the deaths per population that those without helmet laws had, after adjustment for other potential confounding factors, Dr. William P. Meehan III reported at the annual meeting of the Pediatric Academic Societies.

©shironosov/iStockphoto.com

"Twenty-nine states still do not have [laws requiring cyclists to wear helmets], and we think they should be considered," said Dr. Meehan, director of the Micheli Center for Sports Injury Prevention and the Sports Concussion Clinic in the division of sports medicine at Boston Children’s Hospital.

Approximately 900 people die each year in bicycle crashes, three-quarters of them from traumatic brain injuries. On a local level, previous studies have shown that the laws result in increased helmet usage and decreased risk of injury and death in bicycle–motor vehicle collisions.

To assess the effect nationally, Dr. Meehan and his colleagues analyzed data on U.S. bicyclists younger than 16 years of age who died between January 1999 and December 2009. They used the Fatality Analysis Reporting System (FARS) to compare death rates in states with and without mandatory helmet laws. FARS is run by the National Highway Traffic Safety Administration and collects data on all motor vehicle accidents that result in the death of someone involved in a collision.

Over the study period, 1,612 bicyclists under the age of 16 died in a collision with a motor vehicle. The mean unadjusted rate of fatalities was 2 per million in states with helmet laws, versus 2.5 per million in states without the laws. The overall unadjusted incidence rate ratio was 0.83.

After adjustment for three factors that could potentially influence the rate of fatality in bicycle–motor vehicle collisions – elderly driver licensure laws, legal blood alcohol limits (lower than .08% versus .08% or higher), and household income, states with mandatory helmet laws continued to be associated with lower rates of fatalities, with an adjusted incidence rate ratio of 0.84, reported Dr. Meehan, also of the department of pediatrics at Harvard Medical School, Boston.

Because the FARS database includes only collisions that resulted in fatalities – and not other severe injuries – there’s "potentially much greater benefit in helmet legislation" than is reflected by the study findings, he noted.

The American Academy of Pediatrics supports legislation that requires all cyclists to use helmets.

State laws requiring the use of bicycle helmets cover populations up to varying ages, but almost all cover children up to 16 years of age.

At the start of the study period, 16 states had bicycle helmet laws. By the end, in 2009, 19 states and the District of Columbia had helmet laws. (At least two of the additional laws were enacted in the earlier part of the study period). Helmet mandates have also been established by some local municipalities throughout the country, but the analysis covered only states.

The study was funded in part by the Micheli Center for Sports Injury Prevention and the National Institutes of Health. Dr. Meehan reported that he had no relevant financial disclosures.

WASHINGTON – Mandatory bicycle helmet laws are associated with a lower incidence of fatalities among youth cyclists involved in motor vehicle collisions, a national analysis has shown.

States with laws that require bicyclists to wear helmets had only 84% of the deaths per population that those without helmet laws had, after adjustment for other potential confounding factors, Dr. William P. Meehan III reported at the annual meeting of the Pediatric Academic Societies.

©shironosov/iStockphoto.com

"Twenty-nine states still do not have [laws requiring cyclists to wear helmets], and we think they should be considered," said Dr. Meehan, director of the Micheli Center for Sports Injury Prevention and the Sports Concussion Clinic in the division of sports medicine at Boston Children’s Hospital.

Approximately 900 people die each year in bicycle crashes, three-quarters of them from traumatic brain injuries. On a local level, previous studies have shown that the laws result in increased helmet usage and decreased risk of injury and death in bicycle–motor vehicle collisions.

To assess the effect nationally, Dr. Meehan and his colleagues analyzed data on U.S. bicyclists younger than 16 years of age who died between January 1999 and December 2009. They used the Fatality Analysis Reporting System (FARS) to compare death rates in states with and without mandatory helmet laws. FARS is run by the National Highway Traffic Safety Administration and collects data on all motor vehicle accidents that result in the death of someone involved in a collision.

Over the study period, 1,612 bicyclists under the age of 16 died in a collision with a motor vehicle. The mean unadjusted rate of fatalities was 2 per million in states with helmet laws, versus 2.5 per million in states without the laws. The overall unadjusted incidence rate ratio was 0.83.

After adjustment for three factors that could potentially influence the rate of fatality in bicycle–motor vehicle collisions – elderly driver licensure laws, legal blood alcohol limits (lower than .08% versus .08% or higher), and household income, states with mandatory helmet laws continued to be associated with lower rates of fatalities, with an adjusted incidence rate ratio of 0.84, reported Dr. Meehan, also of the department of pediatrics at Harvard Medical School, Boston.

Because the FARS database includes only collisions that resulted in fatalities – and not other severe injuries – there’s "potentially much greater benefit in helmet legislation" than is reflected by the study findings, he noted.

The American Academy of Pediatrics supports legislation that requires all cyclists to use helmets.

State laws requiring the use of bicycle helmets cover populations up to varying ages, but almost all cover children up to 16 years of age.

At the start of the study period, 16 states had bicycle helmet laws. By the end, in 2009, 19 states and the District of Columbia had helmet laws. (At least two of the additional laws were enacted in the earlier part of the study period). Helmet mandates have also been established by some local municipalities throughout the country, but the analysis covered only states.

The study was funded in part by the Micheli Center for Sports Injury Prevention and the National Institutes of Health. Dr. Meehan reported that he had no relevant financial disclosures.

WASHINGTON – Mandatory bicycle helmet laws are associated with a lower incidence of fatalities among youth cyclists involved in motor vehicle collisions, a national analysis has shown.

States with laws that require bicyclists to wear helmets had only 84% of the deaths per population that those without helmet laws had, after adjustment for other potential confounding factors, Dr. William P. Meehan III reported at the annual meeting of the Pediatric Academic Societies.

©shironosov/iStockphoto.com

"Twenty-nine states still do not have [laws requiring cyclists to wear helmets], and we think they should be considered," said Dr. Meehan, director of the Micheli Center for Sports Injury Prevention and the Sports Concussion Clinic in the division of sports medicine at Boston Children’s Hospital.

Approximately 900 people die each year in bicycle crashes, three-quarters of them from traumatic brain injuries. On a local level, previous studies have shown that the laws result in increased helmet usage and decreased risk of injury and death in bicycle–motor vehicle collisions.

To assess the effect nationally, Dr. Meehan and his colleagues analyzed data on U.S. bicyclists younger than 16 years of age who died between January 1999 and December 2009. They used the Fatality Analysis Reporting System (FARS) to compare death rates in states with and without mandatory helmet laws. FARS is run by the National Highway Traffic Safety Administration and collects data on all motor vehicle accidents that result in the death of someone involved in a collision.

Over the study period, 1,612 bicyclists under the age of 16 died in a collision with a motor vehicle. The mean unadjusted rate of fatalities was 2 per million in states with helmet laws, versus 2.5 per million in states without the laws. The overall unadjusted incidence rate ratio was 0.83.

After adjustment for three factors that could potentially influence the rate of fatality in bicycle–motor vehicle collisions – elderly driver licensure laws, legal blood alcohol limits (lower than .08% versus .08% or higher), and household income, states with mandatory helmet laws continued to be associated with lower rates of fatalities, with an adjusted incidence rate ratio of 0.84, reported Dr. Meehan, also of the department of pediatrics at Harvard Medical School, Boston.

Because the FARS database includes only collisions that resulted in fatalities – and not other severe injuries – there’s "potentially much greater benefit in helmet legislation" than is reflected by the study findings, he noted.

The American Academy of Pediatrics supports legislation that requires all cyclists to use helmets.

State laws requiring the use of bicycle helmets cover populations up to varying ages, but almost all cover children up to 16 years of age.

At the start of the study period, 16 states had bicycle helmet laws. By the end, in 2009, 19 states and the District of Columbia had helmet laws. (At least two of the additional laws were enacted in the earlier part of the study period). Helmet mandates have also been established by some local municipalities throughout the country, but the analysis covered only states.

The study was funded in part by the Micheli Center for Sports Injury Prevention and the National Institutes of Health. Dr. Meehan reported that he had no relevant financial disclosures.

ABSTRACT

Background Burnout among physicians can lead to decreased career satisfaction, physical and emotional exhaustion, and increased medical errors. In oncologists, high exposure to fatal illness is associated with burnout.

Methods The Maslach Burnout Inventory, measuring Emotional Exhaustion (EE), Depersonalization (DP), and Personal Accomplishment (PA), was administered to second-year US oncology fellows. Bivariate and multivariate analyses explored associations between burnout and fellow demographics, attitudes, and educational experiences.

Results A total of 254 fellows out of 402 eligible US fellows responded (63.2%) and 24.2% reported high EE, 30.0% reported high DP, and 26.8% reported low PA. Over half of the fellows reported burnout in at least one domain. Lower EE scores were associated with the fellows’ perceptions of having received better teaching, explicit teaching about certain end-of-life topics, and receipt of direct observation of goals-of-care discussions. Fellows who reported better overall teaching quality and more frequent observation of their skills had less depersonalization. Fellows who felt a responsibility to help patients at the end of life to prepare for death had higher PA.

Limitations This survey relies on the fellows’ self-reported perceptions without an objective measure for validation. Factors associated with burnout may not be causal. The number of analyses performed raises the concern for Type I errors; therefore, a stringent P value (.01) was used.

Conclusions Burnout is prevalent during oncology training. Higher-quality teaching is associated with less burnout among fellows. Fellowship programs should recognize the prevalence of burnout among oncology fellows as well as components of training that may protect against burnout.

*For a PDF of the full article, click on the link to the left of this introduction.

ABSTRACT

Background Burnout among physicians can lead to decreased career satisfaction, physical and emotional exhaustion, and increased medical errors. In oncologists, high exposure to fatal illness is associated with burnout.

Methods The Maslach Burnout Inventory, measuring Emotional Exhaustion (EE), Depersonalization (DP), and Personal Accomplishment (PA), was administered to second-year US oncology fellows. Bivariate and multivariate analyses explored associations between burnout and fellow demographics, attitudes, and educational experiences.

Results A total of 254 fellows out of 402 eligible US fellows responded (63.2%) and 24.2% reported high EE, 30.0% reported high DP, and 26.8% reported low PA. Over half of the fellows reported burnout in at least one domain. Lower EE scores were associated with the fellows’ perceptions of having received better teaching, explicit teaching about certain end-of-life topics, and receipt of direct observation of goals-of-care discussions. Fellows who reported better overall teaching quality and more frequent observation of their skills had less depersonalization. Fellows who felt a responsibility to help patients at the end of life to prepare for death had higher PA.

Limitations This survey relies on the fellows’ self-reported perceptions without an objective measure for validation. Factors associated with burnout may not be causal. The number of analyses performed raises the concern for Type I errors; therefore, a stringent P value (.01) was used.

Conclusions Burnout is prevalent during oncology training. Higher-quality teaching is associated with less burnout among fellows. Fellowship programs should recognize the prevalence of burnout among oncology fellows as well as components of training that may protect against burnout.

*For a PDF of the full article, click on the link to the left of this introduction.

ABSTRACT

Background Burnout among physicians can lead to decreased career satisfaction, physical and emotional exhaustion, and increased medical errors. In oncologists, high exposure to fatal illness is associated with burnout.

Methods The Maslach Burnout Inventory, measuring Emotional Exhaustion (EE), Depersonalization (DP), and Personal Accomplishment (PA), was administered to second-year US oncology fellows. Bivariate and multivariate analyses explored associations between burnout and fellow demographics, attitudes, and educational experiences.

Results A total of 254 fellows out of 402 eligible US fellows responded (63.2%) and 24.2% reported high EE, 30.0% reported high DP, and 26.8% reported low PA. Over half of the fellows reported burnout in at least one domain. Lower EE scores were associated with the fellows’ perceptions of having received better teaching, explicit teaching about certain end-of-life topics, and receipt of direct observation of goals-of-care discussions. Fellows who reported better overall teaching quality and more frequent observation of their skills had less depersonalization. Fellows who felt a responsibility to help patients at the end of life to prepare for death had higher PA.

Limitations This survey relies on the fellows’ self-reported perceptions without an objective measure for validation. Factors associated with burnout may not be causal. The number of analyses performed raises the concern for Type I errors; therefore, a stringent P value (.01) was used.

Conclusions Burnout is prevalent during oncology training. Higher-quality teaching is associated with less burnout among fellows. Fellowship programs should recognize the prevalence of burnout among oncology fellows as well as components of training that may protect against burnout.

*For a PDF of the full article, click on the link to the left of this introduction.

Most people believe that nocturnists should get paid 20% to 33% more than their day-shift counterparts, according to a recent survey at www.the-hospitalist.org. Results of the survey, however, do not necessarily reflect the realities of supply and demand in local markets, according to members of SHM’s Practice Analysis Committee.

Practice size, volume of work, and the inconvenience of working at night contribute to the amount nocturnists get paid, says Leslie Flores, MHA, a committee member and partner in Nelson Flores Hospital Medicine Consultants. “We usually see a range between [a] 15% to 20% premium for nocturnist work,” she adds.

Survey respondents were asked to choose how much of a premium nocturnists should get paid, with the answers ranging from 20% to 60% to the same as everyone else. Two-thirds of the 212 respondents chose 20% or 33% bonus pay for nocturnists; 17% chose “the same as everyone else”; and another 17% chose 50% or 66%.

Committee member Troy Ahlstrom, MD, SFHM, senior chief information officer at Hospitals of Northern Michigan, says the survey does not reflect the reality of important factors that influence the market, such as supply and demand for nocturnists, local and regional factors that impact the level of supply and demand, and economic influence nationally.

“If you ask a practice manager or a hospital administrator that question, they would say nocturnists should make whatever is necessary to meet the demands for filling that job,” Dr. Ahlstrom says. “It’s a market-driven phenomenon.”

Hospitals don’t want to pay more, he notes, but they do want “to pay the right amount for the right job.”

Check out our website for more information about hospitalist compensation.

Most people believe that nocturnists should get paid 20% to 33% more than their day-shift counterparts, according to a recent survey at www.the-hospitalist.org. Results of the survey, however, do not necessarily reflect the realities of supply and demand in local markets, according to members of SHM’s Practice Analysis Committee.

Practice size, volume of work, and the inconvenience of working at night contribute to the amount nocturnists get paid, says Leslie Flores, MHA, a committee member and partner in Nelson Flores Hospital Medicine Consultants. “We usually see a range between [a] 15% to 20% premium for nocturnist work,” she adds.

Survey respondents were asked to choose how much of a premium nocturnists should get paid, with the answers ranging from 20% to 60% to the same as everyone else. Two-thirds of the 212 respondents chose 20% or 33% bonus pay for nocturnists; 17% chose “the same as everyone else”; and another 17% chose 50% or 66%.

Committee member Troy Ahlstrom, MD, SFHM, senior chief information officer at Hospitals of Northern Michigan, says the survey does not reflect the reality of important factors that influence the market, such as supply and demand for nocturnists, local and regional factors that impact the level of supply and demand, and economic influence nationally.

“If you ask a practice manager or a hospital administrator that question, they would say nocturnists should make whatever is necessary to meet the demands for filling that job,” Dr. Ahlstrom says. “It’s a market-driven phenomenon.”

Hospitals don’t want to pay more, he notes, but they do want “to pay the right amount for the right job.”

Check out our website for more information about hospitalist compensation.

Most people believe that nocturnists should get paid 20% to 33% more than their day-shift counterparts, according to a recent survey at www.the-hospitalist.org. Results of the survey, however, do not necessarily reflect the realities of supply and demand in local markets, according to members of SHM’s Practice Analysis Committee.

Practice size, volume of work, and the inconvenience of working at night contribute to the amount nocturnists get paid, says Leslie Flores, MHA, a committee member and partner in Nelson Flores Hospital Medicine Consultants. “We usually see a range between [a] 15% to 20% premium for nocturnist work,” she adds.

Survey respondents were asked to choose how much of a premium nocturnists should get paid, with the answers ranging from 20% to 60% to the same as everyone else. Two-thirds of the 212 respondents chose 20% or 33% bonus pay for nocturnists; 17% chose “the same as everyone else”; and another 17% chose 50% or 66%.

Committee member Troy Ahlstrom, MD, SFHM, senior chief information officer at Hospitals of Northern Michigan, says the survey does not reflect the reality of important factors that influence the market, such as supply and demand for nocturnists, local and regional factors that impact the level of supply and demand, and economic influence nationally.

“If you ask a practice manager or a hospital administrator that question, they would say nocturnists should make whatever is necessary to meet the demands for filling that job,” Dr. Ahlstrom says. “It’s a market-driven phenomenon.”

Hospitals don’t want to pay more, he notes, but they do want “to pay the right amount for the right job.”

Check out our website for more information about hospitalist compensation.

Clinical question: Does fluid management guided by daily plasma natriuretic peptide-driven (BNP) levels in mechanically ventilated patients improve weaning outcomes compared with usual therapy dictated by clinical acumen?

Background: Ventilator weaning contributes at least 40% of the total duration of mechanical ventilation; strategies aimed at optimizing this process could provide substantial benefit. Previous studies have demonstrated that BNP levels prior to ventilator weaning independently predict weaning failure. No current objective practical guide to fluid management during ventilator weaning exists.

Study design: Randomized controlled trial.

Setting: Multiple international centers.

Synopsis: Three hundred four patients who met specific inclusion and exclusion criteria were randomized to either a BNP-driven or physician-guided strategy for fluid management during ventilator weaning. Patients with renal failure were excluded because of the influence of renal function on BNP levels.

All patients in both groups were ventilated with an automatic computer-driven weaning system to standardize the weaning process. In the BNP-driven group, diuretic use was higher, resulting in a more negative fluid balance and significantly shorter time to successful extubation (58.6 hours vs. 42.2 hours, P=0.03). The effect on weaning time was strongest in patients with left ventricular systolic dysfunction, whereas those with COPD seemed less likely to benefit. The two groups did not differ in baseline characteristics, length of stay, mortality, or development of adverse outcomes of renal failure, shock, or electrolyte disturbances.

Bottom line: Compared with physician-guided fluid management, a BNP-driven fluid management protocol decreased duration of ventilator weaning without significant differences in adverse events, mortality rate, or length of stay between the two groups.

Citation: Dessap AM, Roche-Campo F, Kouatchet A, et al. Natriuretic peptide-driven fluid management during ventilator weaning. Am J Respir Crit Care Med. 2012;186(12):1256-1263.

Visit our website for more physician reviews of recent HM-relevant literature.

Clinical question: Does fluid management guided by daily plasma natriuretic peptide-driven (BNP) levels in mechanically ventilated patients improve weaning outcomes compared with usual therapy dictated by clinical acumen?

Background: Ventilator weaning contributes at least 40% of the total duration of mechanical ventilation; strategies aimed at optimizing this process could provide substantial benefit. Previous studies have demonstrated that BNP levels prior to ventilator weaning independently predict weaning failure. No current objective practical guide to fluid management during ventilator weaning exists.

Study design: Randomized controlled trial.

Setting: Multiple international centers.

Synopsis: Three hundred four patients who met specific inclusion and exclusion criteria were randomized to either a BNP-driven or physician-guided strategy for fluid management during ventilator weaning. Patients with renal failure were excluded because of the influence of renal function on BNP levels.

All patients in both groups were ventilated with an automatic computer-driven weaning system to standardize the weaning process. In the BNP-driven group, diuretic use was higher, resulting in a more negative fluid balance and significantly shorter time to successful extubation (58.6 hours vs. 42.2 hours, P=0.03). The effect on weaning time was strongest in patients with left ventricular systolic dysfunction, whereas those with COPD seemed less likely to benefit. The two groups did not differ in baseline characteristics, length of stay, mortality, or development of adverse outcomes of renal failure, shock, or electrolyte disturbances.

Bottom line: Compared with physician-guided fluid management, a BNP-driven fluid management protocol decreased duration of ventilator weaning without significant differences in adverse events, mortality rate, or length of stay between the two groups.

Citation: Dessap AM, Roche-Campo F, Kouatchet A, et al. Natriuretic peptide-driven fluid management during ventilator weaning. Am J Respir Crit Care Med. 2012;186(12):1256-1263.

Visit our website for more physician reviews of recent HM-relevant literature.

Clinical question: Does fluid management guided by daily plasma natriuretic peptide-driven (BNP) levels in mechanically ventilated patients improve weaning outcomes compared with usual therapy dictated by clinical acumen?

Background: Ventilator weaning contributes at least 40% of the total duration of mechanical ventilation; strategies aimed at optimizing this process could provide substantial benefit. Previous studies have demonstrated that BNP levels prior to ventilator weaning independently predict weaning failure. No current objective practical guide to fluid management during ventilator weaning exists.

Study design: Randomized controlled trial.

Setting: Multiple international centers.

Synopsis: Three hundred four patients who met specific inclusion and exclusion criteria were randomized to either a BNP-driven or physician-guided strategy for fluid management during ventilator weaning. Patients with renal failure were excluded because of the influence of renal function on BNP levels.

All patients in both groups were ventilated with an automatic computer-driven weaning system to standardize the weaning process. In the BNP-driven group, diuretic use was higher, resulting in a more negative fluid balance and significantly shorter time to successful extubation (58.6 hours vs. 42.2 hours, P=0.03). The effect on weaning time was strongest in patients with left ventricular systolic dysfunction, whereas those with COPD seemed less likely to benefit. The two groups did not differ in baseline characteristics, length of stay, mortality, or development of adverse outcomes of renal failure, shock, or electrolyte disturbances.

Bottom line: Compared with physician-guided fluid management, a BNP-driven fluid management protocol decreased duration of ventilator weaning without significant differences in adverse events, mortality rate, or length of stay between the two groups.

Citation: Dessap AM, Roche-Campo F, Kouatchet A, et al. Natriuretic peptide-driven fluid management during ventilator weaning. Am J Respir Crit Care Med. 2012;186(12):1256-1263.

Visit our website for more physician reviews of recent HM-relevant literature.

ORLANDO – The risk factors for death in patients with nonalcoholic fatty liver disease include older age, male sex, truncal obesity, and a low HDL cholesterol level – in other words, the same factors that increase risk for death from cardiovascular disease and other causes, according to Dr. Naga P. Chalasani.

On the other hand, elevations in alanine aminotransferase (ALT) levels in patients with NAFLD are not associated with an increased risk for death or other poor outcomes, meaning that researchers may have to burrow more deeply through the available data to find risk predictors unique to NAFLD, said Dr Chalasani of Indiana University, Indianapolis.

"How do we identify someone with NAFLD who is at risk for poor outcomes? I think this is the first shot at risk mapping patients," Dr. Chalasani said at the annual Digestive Disease Week.

Dr. Keith D. Lindor, who moderated the session at which the data were presented, agreed.

"What we’re having trouble with, I think, is defining nonalcoholic fatty liver disease easily, particularly amongst the population," he said. "We saw data that ALT, which we commonly used to use, may not be telling, and there are questions about how well ultrasound detects [NAFLD], particularly given that the amount of steatosis in order to be detected by ultrasound has to be relatively dramatic."

It is still not known whether people with steatosis discovered during biopsy but not visible on ultrasound will have risk factors similar to those of people with more grossly evident steatosis, he said in an interview.

Although Dr. Chalasani and colleagues failed to find unique risk markers in this population, it was not for want of trying. The investigators pored over data from the third National Health and Nutrition Examination Survey (NHANES III) for baseline and follow-up information about patients with NAFLD.

The data were collected from 1988 through 1994, and included gallbladder ultrasound with liver images in 14,797 adults aged 20-74. The authors linked the data to the National Death Index in an attempt to determine which factors might be harbingers of early mortality in patients with NAFLD vs. controls.

They defined NAFLD by the presence of moderate to severe hepatic steatosis on ultrasonography, and by the absence of iron overload, hepatitis B or C infections, and excessive alcohol consumption. Controls were participants in the same data set who did not have underlying liver disease and had normal ultrasound and liver function tests.

There were a total of 2,441 people with NAFLD and 8,423 controls. During a median follow-up of 14.3 years, 14% of controls (1,193), and 21% of those with NAFLD (501) died, a difference that was significant in a univariate analysis (P = .0328).

But when they looked at overall mortality, cancer-related mortality, and cardiovascular mortality, they found that all three categories shared male sex, older age, and a low HDL level as independent predictors for death, with cardiovascular mortality having the added bonus of the metabolic syndrome as an additional risk factor.

The authors did not disclose a funding source. Dr. Chalasani and Dr. Lindor reported having no relevant financial disclosures.

ORLANDO – The risk factors for death in patients with nonalcoholic fatty liver disease include older age, male sex, truncal obesity, and a low HDL cholesterol level – in other words, the same factors that increase risk for death from cardiovascular disease and other causes, according to Dr. Naga P. Chalasani.

On the other hand, elevations in alanine aminotransferase (ALT) levels in patients with NAFLD are not associated with an increased risk for death or other poor outcomes, meaning that researchers may have to burrow more deeply through the available data to find risk predictors unique to NAFLD, said Dr Chalasani of Indiana University, Indianapolis.

"How do we identify someone with NAFLD who is at risk for poor outcomes? I think this is the first shot at risk mapping patients," Dr. Chalasani said at the annual Digestive Disease Week.

Dr. Keith D. Lindor, who moderated the session at which the data were presented, agreed.

"What we’re having trouble with, I think, is defining nonalcoholic fatty liver disease easily, particularly amongst the population," he said. "We saw data that ALT, which we commonly used to use, may not be telling, and there are questions about how well ultrasound detects [NAFLD], particularly given that the amount of steatosis in order to be detected by ultrasound has to be relatively dramatic."

It is still not known whether people with steatosis discovered during biopsy but not visible on ultrasound will have risk factors similar to those of people with more grossly evident steatosis, he said in an interview.

Although Dr. Chalasani and colleagues failed to find unique risk markers in this population, it was not for want of trying. The investigators pored over data from the third National Health and Nutrition Examination Survey (NHANES III) for baseline and follow-up information about patients with NAFLD.

The data were collected from 1988 through 1994, and included gallbladder ultrasound with liver images in 14,797 adults aged 20-74. The authors linked the data to the National Death Index in an attempt to determine which factors might be harbingers of early mortality in patients with NAFLD vs. controls.

They defined NAFLD by the presence of moderate to severe hepatic steatosis on ultrasonography, and by the absence of iron overload, hepatitis B or C infections, and excessive alcohol consumption. Controls were participants in the same data set who did not have underlying liver disease and had normal ultrasound and liver function tests.

There were a total of 2,441 people with NAFLD and 8,423 controls. During a median follow-up of 14.3 years, 14% of controls (1,193), and 21% of those with NAFLD (501) died, a difference that was significant in a univariate analysis (P = .0328).

But when they looked at overall mortality, cancer-related mortality, and cardiovascular mortality, they found that all three categories shared male sex, older age, and a low HDL level as independent predictors for death, with cardiovascular mortality having the added bonus of the metabolic syndrome as an additional risk factor.

The authors did not disclose a funding source. Dr. Chalasani and Dr. Lindor reported having no relevant financial disclosures.

ORLANDO – The risk factors for death in patients with nonalcoholic fatty liver disease include older age, male sex, truncal obesity, and a low HDL cholesterol level – in other words, the same factors that increase risk for death from cardiovascular disease and other causes, according to Dr. Naga P. Chalasani.

On the other hand, elevations in alanine aminotransferase (ALT) levels in patients with NAFLD are not associated with an increased risk for death or other poor outcomes, meaning that researchers may have to burrow more deeply through the available data to find risk predictors unique to NAFLD, said Dr Chalasani of Indiana University, Indianapolis.

"How do we identify someone with NAFLD who is at risk for poor outcomes? I think this is the first shot at risk mapping patients," Dr. Chalasani said at the annual Digestive Disease Week.

Dr. Keith D. Lindor, who moderated the session at which the data were presented, agreed.

"What we’re having trouble with, I think, is defining nonalcoholic fatty liver disease easily, particularly amongst the population," he said. "We saw data that ALT, which we commonly used to use, may not be telling, and there are questions about how well ultrasound detects [NAFLD], particularly given that the amount of steatosis in order to be detected by ultrasound has to be relatively dramatic."

It is still not known whether people with steatosis discovered during biopsy but not visible on ultrasound will have risk factors similar to those of people with more grossly evident steatosis, he said in an interview.

Although Dr. Chalasani and colleagues failed to find unique risk markers in this population, it was not for want of trying. The investigators pored over data from the third National Health and Nutrition Examination Survey (NHANES III) for baseline and follow-up information about patients with NAFLD.

The data were collected from 1988 through 1994, and included gallbladder ultrasound with liver images in 14,797 adults aged 20-74. The authors linked the data to the National Death Index in an attempt to determine which factors might be harbingers of early mortality in patients with NAFLD vs. controls.

They defined NAFLD by the presence of moderate to severe hepatic steatosis on ultrasonography, and by the absence of iron overload, hepatitis B or C infections, and excessive alcohol consumption. Controls were participants in the same data set who did not have underlying liver disease and had normal ultrasound and liver function tests.

There were a total of 2,441 people with NAFLD and 8,423 controls. During a median follow-up of 14.3 years, 14% of controls (1,193), and 21% of those with NAFLD (501) died, a difference that was significant in a univariate analysis (P = .0328).

But when they looked at overall mortality, cancer-related mortality, and cardiovascular mortality, they found that all three categories shared male sex, older age, and a low HDL level as independent predictors for death, with cardiovascular mortality having the added bonus of the metabolic syndrome as an additional risk factor.

The authors did not disclose a funding source. Dr. Chalasani and Dr. Lindor reported having no relevant financial disclosures.

ORLANDO – Changes in serum levels of cytokeratin fragments appear to reflect changes in liver histology in patients with nonalcoholic steatohepatitis, Dr. Raj Vuppalanchi reported at the annual Digestive Disease Week.

Among 231 participants in the PIVENS (Pioglitazone versus Vitamin E versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis) trial, every 100-U/L decline in serum cytokeratin fragment (CK-18) level was significantly associated with overall histological improvement (P less than .001); resolution of NASH (P = .002); and improvement of at least 1 point in steatosis grade, hepatocellular ballooning, and nonalcoholic fatty liver disease (NAFLD) score (P less than .001 for all).

"We feel that serum CK-18 is a potentially useful surrogate marker for detection of improvement in clinical trials for NASH," said Dr. Vuppalanchi from Indiana University in Indianapolis.

Dr. Keith D. Lindor, executive vice provost for health at Arizona State University in Phoenix, said in an interview that CK-18 shows promise as a marker for disease activity in NASH but offers only limited information.

"It doesn’t hold the possibility of giving as much detailed information as a biopsy. We look at the amount of fat, amount of inflammation, amount of scarring – the biopsy lets us do that, but I don’t think a single serum assay will allow that," he said.

Dr. Lindor, who was not involved in the study, moderated the session at which the data were presented.

In previous cross-sectional studies, circulating CK-18 levels were shown to be associated with steatohepatitis in people with NAFLD, but it was unclear whether longitudinal changes in CK-18 would reflect changes in liver histology, Dr. Vuppalanchi said.

The investigators looked at CK-18 levels measured at baseline and at 16, 48, and 96 months among 231 of the 247 patients enrolled in the PIVENS trial, which compared vitamin E and/or pioglitazone against placebo in nondiabetic patients with NASH. The participants had liver biopsies at baseline and after 96 weeks of treatment.

The main trial results showed that vitamin E, but not pioglitazone, was significantly better than placebo at improvement of steatohepatitis.

In this substudy, the authors found that, compared with placebo, serum CK-18 levels were significantly lower in vitamin E–treated patients (P = .02 at 16 weeks, and P = .009 at 48 and 96 weeks). Among pioglitazone-treated patients, there was a similar pattern of lower CK-18 levels vs. placebo at all three time intervals (P = .001 for all).

Reductions in CK-18 correlated strongly with disease measures. For each 100-U/L decrease in CK-18 over 96 weeks, the odds ratios (ORs) were as follows: overall histological improvement (OR, 1.41; P less than .001); resolution of NASH (OR, 1.31; P = .002); and 1 point or more improvement in steatosis grade (OR, 1.45; P less than .001), hepatocellular ballooning (OR, 1.36; P less than .001), and NAFLD (OR, 1.41; P less than .001).

The study was supported by the National Institutes of Health with additional funding from Takeda Pharmaceuticals. Dr. Vuppalanchi and Dr. Lindor reported having no financial disclosures.

ORLANDO – Changes in serum levels of cytokeratin fragments appear to reflect changes in liver histology in patients with nonalcoholic steatohepatitis, Dr. Raj Vuppalanchi reported at the annual Digestive Disease Week.

Among 231 participants in the PIVENS (Pioglitazone versus Vitamin E versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis) trial, every 100-U/L decline in serum cytokeratin fragment (CK-18) level was significantly associated with overall histological improvement (P less than .001); resolution of NASH (P = .002); and improvement of at least 1 point in steatosis grade, hepatocellular ballooning, and nonalcoholic fatty liver disease (NAFLD) score (P less than .001 for all).

"We feel that serum CK-18 is a potentially useful surrogate marker for detection of improvement in clinical trials for NASH," said Dr. Vuppalanchi from Indiana University in Indianapolis.

Dr. Keith D. Lindor, executive vice provost for health at Arizona State University in Phoenix, said in an interview that CK-18 shows promise as a marker for disease activity in NASH but offers only limited information.

"It doesn’t hold the possibility of giving as much detailed information as a biopsy. We look at the amount of fat, amount of inflammation, amount of scarring – the biopsy lets us do that, but I don’t think a single serum assay will allow that," he said.

Dr. Lindor, who was not involved in the study, moderated the session at which the data were presented.

In previous cross-sectional studies, circulating CK-18 levels were shown to be associated with steatohepatitis in people with NAFLD, but it was unclear whether longitudinal changes in CK-18 would reflect changes in liver histology, Dr. Vuppalanchi said.

The investigators looked at CK-18 levels measured at baseline and at 16, 48, and 96 months among 231 of the 247 patients enrolled in the PIVENS trial, which compared vitamin E and/or pioglitazone against placebo in nondiabetic patients with NASH. The participants had liver biopsies at baseline and after 96 weeks of treatment.

The main trial results showed that vitamin E, but not pioglitazone, was significantly better than placebo at improvement of steatohepatitis.

In this substudy, the authors found that, compared with placebo, serum CK-18 levels were significantly lower in vitamin E–treated patients (P = .02 at 16 weeks, and P = .009 at 48 and 96 weeks). Among pioglitazone-treated patients, there was a similar pattern of lower CK-18 levels vs. placebo at all three time intervals (P = .001 for all).

Reductions in CK-18 correlated strongly with disease measures. For each 100-U/L decrease in CK-18 over 96 weeks, the odds ratios (ORs) were as follows: overall histological improvement (OR, 1.41; P less than .001); resolution of NASH (OR, 1.31; P = .002); and 1 point or more improvement in steatosis grade (OR, 1.45; P less than .001), hepatocellular ballooning (OR, 1.36; P less than .001), and NAFLD (OR, 1.41; P less than .001).

The study was supported by the National Institutes of Health with additional funding from Takeda Pharmaceuticals. Dr. Vuppalanchi and Dr. Lindor reported having no financial disclosures.

ORLANDO – Changes in serum levels of cytokeratin fragments appear to reflect changes in liver histology in patients with nonalcoholic steatohepatitis, Dr. Raj Vuppalanchi reported at the annual Digestive Disease Week.

Among 231 participants in the PIVENS (Pioglitazone versus Vitamin E versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis) trial, every 100-U/L decline in serum cytokeratin fragment (CK-18) level was significantly associated with overall histological improvement (P less than .001); resolution of NASH (P = .002); and improvement of at least 1 point in steatosis grade, hepatocellular ballooning, and nonalcoholic fatty liver disease (NAFLD) score (P less than .001 for all).

"We feel that serum CK-18 is a potentially useful surrogate marker for detection of improvement in clinical trials for NASH," said Dr. Vuppalanchi from Indiana University in Indianapolis.

Dr. Keith D. Lindor, executive vice provost for health at Arizona State University in Phoenix, said in an interview that CK-18 shows promise as a marker for disease activity in NASH but offers only limited information.

"It doesn’t hold the possibility of giving as much detailed information as a biopsy. We look at the amount of fat, amount of inflammation, amount of scarring – the biopsy lets us do that, but I don’t think a single serum assay will allow that," he said.

Dr. Lindor, who was not involved in the study, moderated the session at which the data were presented.

In previous cross-sectional studies, circulating CK-18 levels were shown to be associated with steatohepatitis in people with NAFLD, but it was unclear whether longitudinal changes in CK-18 would reflect changes in liver histology, Dr. Vuppalanchi said.

The investigators looked at CK-18 levels measured at baseline and at 16, 48, and 96 months among 231 of the 247 patients enrolled in the PIVENS trial, which compared vitamin E and/or pioglitazone against placebo in nondiabetic patients with NASH. The participants had liver biopsies at baseline and after 96 weeks of treatment.

The main trial results showed that vitamin E, but not pioglitazone, was significantly better than placebo at improvement of steatohepatitis.

In this substudy, the authors found that, compared with placebo, serum CK-18 levels were significantly lower in vitamin E–treated patients (P = .02 at 16 weeks, and P = .009 at 48 and 96 weeks). Among pioglitazone-treated patients, there was a similar pattern of lower CK-18 levels vs. placebo at all three time intervals (P = .001 for all).

Reductions in CK-18 correlated strongly with disease measures. For each 100-U/L decrease in CK-18 over 96 weeks, the odds ratios (ORs) were as follows: overall histological improvement (OR, 1.41; P less than .001); resolution of NASH (OR, 1.31; P = .002); and 1 point or more improvement in steatosis grade (OR, 1.45; P less than .001), hepatocellular ballooning (OR, 1.36; P less than .001), and NAFLD (OR, 1.41; P less than .001).

The study was supported by the National Institutes of Health with additional funding from Takeda Pharmaceuticals. Dr. Vuppalanchi and Dr. Lindor reported having no financial disclosures.

ORLANDO – In patients with Crohn’s disease, a response to the investigational monoclonal antibody vedoluzimab within 6 weeks of initiating therapy was predictive of a continued response to the drug, even at lower doses.

Among patients in the GEMINI II trial with a documented response to vedoluzimab after 6 weeks, 32% of those who were then randomized to receive the drug once every 8 weeks for an additional 46 weeks had a corticosteroid-free clinical remission of Crohn’s disease (CD), as did 29% of those who continued to receive the same dose every 4 weeks and 16% of those on placebo, said Dr. William Sandborn at the annual Digestive Disease Week.

However, the rate of durable clinical remissions, defined as clinical remissions at 80% or more of study visits, was comparable for both dosing groups and the placebo group.

"Patients who had a clinical response to vedolizumab by week 6 then went on to have stable clinical remission rates throughout the maintenance phase and significantly higher clinical remission rates than placebo by week 52," said Dr. Sandborn of the University of California, San Diego.

Vedolizumab is an investigational, gut-selective monoclonal antibody targeting the alpha-4 beta-7 integrin. In GEMINI II, the drug was shown to be more effective than placebo for induction and maintenance therapy of CD.

For this analysis, the researchers dug deeper into the data from GEMINI II and looked at maintenance-phase outcomes for those patients who had a clinical response to the drug by week 6 of the trial.

Patients in the trial were adults 18-80 years old with a diagnosis of CD at least 3 months before study entry, moderate to severe CD as determined by a CD Activity Index (CDAI) score of 220-450 at screening, and either intolerance of or an inadequate response to purine antimetabolites or anti–tumor necrosis factor (anti-TNF) agents.

A clinical response to vedolizumab was defined as at least a 70-point decline in CDAI score from baseline value at week 6 following two induction doses of therapy. Patients were randomized on a 1:1:1 basis to receive vedolizumab via infusion every 8 weeks, the same dose every 4 weeks, or placebo until week 52.

Patients who did not have a clinical response by week 6 were treated with open-label vedolizumab at the 300-mg dose every 8 weeks until week 52, and were assessed with those patients who had been on placebo throughout the induction and maintenance phases.

CDAI scores among 153 patients on placebo stabilized at 26 weeks, but continued to decline through week 52 among patients on vedolizumab at both dosing frequencies (154 patients in each dosing group). Rates of clinical remission (CDAI score of 150 or lower) remained relatively stable among patients on vedolizumab, but declined among those on placebo.

A corticosteroid-free remission was seen at week 52 in 32% of patients on the 8-week schedule and in 16% of those on placebo (P = .015). The remission rate was 29% for those on the 4-week schedule (P vs. placebo = .045).

In addition, 21% of those on vedolizumab every 8 weeks had durable clinical remissions, as did 16% of those on the every-4-week dose and 14% of those on placebo. There were no statistically significant differences among the three groups.

In the question-and-answer session following presentation of the results, an attendee commented that "it’s a little disturbing that the more frequent dose seemed to be numerically inferior to the less-frequent dose at virtually every measured outcome."

Dr. Sandborn said that the investigators have extensively examined that question and determined that "there’s noise around the measurements, but you couldn’t draw any firm statistical conclusions."

The study was funded by Millennium/Takeda. Dr. Sandborn disclosed serving as a consultant and receiving grant and research support from the combined companies.

ORLANDO – In patients with Crohn’s disease, a response to the investigational monoclonal antibody vedoluzimab within 6 weeks of initiating therapy was predictive of a continued response to the drug, even at lower doses.

Among patients in the GEMINI II trial with a documented response to vedoluzimab after 6 weeks, 32% of those who were then randomized to receive the drug once every 8 weeks for an additional 46 weeks had a corticosteroid-free clinical remission of Crohn’s disease (CD), as did 29% of those who continued to receive the same dose every 4 weeks and 16% of those on placebo, said Dr. William Sandborn at the annual Digestive Disease Week.

However, the rate of durable clinical remissions, defined as clinical remissions at 80% or more of study visits, was comparable for both dosing groups and the placebo group.

"Patients who had a clinical response to vedolizumab by week 6 then went on to have stable clinical remission rates throughout the maintenance phase and significantly higher clinical remission rates than placebo by week 52," said Dr. Sandborn of the University of California, San Diego.

Vedolizumab is an investigational, gut-selective monoclonal antibody targeting the alpha-4 beta-7 integrin. In GEMINI II, the drug was shown to be more effective than placebo for induction and maintenance therapy of CD.

For this analysis, the researchers dug deeper into the data from GEMINI II and looked at maintenance-phase outcomes for those patients who had a clinical response to the drug by week 6 of the trial.

Patients in the trial were adults 18-80 years old with a diagnosis of CD at least 3 months before study entry, moderate to severe CD as determined by a CD Activity Index (CDAI) score of 220-450 at screening, and either intolerance of or an inadequate response to purine antimetabolites or anti–tumor necrosis factor (anti-TNF) agents.

A clinical response to vedolizumab was defined as at least a 70-point decline in CDAI score from baseline value at week 6 following two induction doses of therapy. Patients were randomized on a 1:1:1 basis to receive vedolizumab via infusion every 8 weeks, the same dose every 4 weeks, or placebo until week 52.

Patients who did not have a clinical response by week 6 were treated with open-label vedolizumab at the 300-mg dose every 8 weeks until week 52, and were assessed with those patients who had been on placebo throughout the induction and maintenance phases.

CDAI scores among 153 patients on placebo stabilized at 26 weeks, but continued to decline through week 52 among patients on vedolizumab at both dosing frequencies (154 patients in each dosing group). Rates of clinical remission (CDAI score of 150 or lower) remained relatively stable among patients on vedolizumab, but declined among those on placebo.

A corticosteroid-free remission was seen at week 52 in 32% of patients on the 8-week schedule and in 16% of those on placebo (P = .015). The remission rate was 29% for those on the 4-week schedule (P vs. placebo = .045).

In addition, 21% of those on vedolizumab every 8 weeks had durable clinical remissions, as did 16% of those on the every-4-week dose and 14% of those on placebo. There were no statistically significant differences among the three groups.

In the question-and-answer session following presentation of the results, an attendee commented that "it’s a little disturbing that the more frequent dose seemed to be numerically inferior to the less-frequent dose at virtually every measured outcome."

Dr. Sandborn said that the investigators have extensively examined that question and determined that "there’s noise around the measurements, but you couldn’t draw any firm statistical conclusions."

The study was funded by Millennium/Takeda. Dr. Sandborn disclosed serving as a consultant and receiving grant and research support from the combined companies.

ORLANDO – In patients with Crohn’s disease, a response to the investigational monoclonal antibody vedoluzimab within 6 weeks of initiating therapy was predictive of a continued response to the drug, even at lower doses.

Among patients in the GEMINI II trial with a documented response to vedoluzimab after 6 weeks, 32% of those who were then randomized to receive the drug once every 8 weeks for an additional 46 weeks had a corticosteroid-free clinical remission of Crohn’s disease (CD), as did 29% of those who continued to receive the same dose every 4 weeks and 16% of those on placebo, said Dr. William Sandborn at the annual Digestive Disease Week.

However, the rate of durable clinical remissions, defined as clinical remissions at 80% or more of study visits, was comparable for both dosing groups and the placebo group.

"Patients who had a clinical response to vedolizumab by week 6 then went on to have stable clinical remission rates throughout the maintenance phase and significantly higher clinical remission rates than placebo by week 52," said Dr. Sandborn of the University of California, San Diego.

Vedolizumab is an investigational, gut-selective monoclonal antibody targeting the alpha-4 beta-7 integrin. In GEMINI II, the drug was shown to be more effective than placebo for induction and maintenance therapy of CD.

For this analysis, the researchers dug deeper into the data from GEMINI II and looked at maintenance-phase outcomes for those patients who had a clinical response to the drug by week 6 of the trial.

Patients in the trial were adults 18-80 years old with a diagnosis of CD at least 3 months before study entry, moderate to severe CD as determined by a CD Activity Index (CDAI) score of 220-450 at screening, and either intolerance of or an inadequate response to purine antimetabolites or anti–tumor necrosis factor (anti-TNF) agents.

A clinical response to vedolizumab was defined as at least a 70-point decline in CDAI score from baseline value at week 6 following two induction doses of therapy. Patients were randomized on a 1:1:1 basis to receive vedolizumab via infusion every 8 weeks, the same dose every 4 weeks, or placebo until week 52.

Patients who did not have a clinical response by week 6 were treated with open-label vedolizumab at the 300-mg dose every 8 weeks until week 52, and were assessed with those patients who had been on placebo throughout the induction and maintenance phases.

CDAI scores among 153 patients on placebo stabilized at 26 weeks, but continued to decline through week 52 among patients on vedolizumab at both dosing frequencies (154 patients in each dosing group). Rates of clinical remission (CDAI score of 150 or lower) remained relatively stable among patients on vedolizumab, but declined among those on placebo.

A corticosteroid-free remission was seen at week 52 in 32% of patients on the 8-week schedule and in 16% of those on placebo (P = .015). The remission rate was 29% for those on the 4-week schedule (P vs. placebo = .045).

In addition, 21% of those on vedolizumab every 8 weeks had durable clinical remissions, as did 16% of those on the every-4-week dose and 14% of those on placebo. There were no statistically significant differences among the three groups.

In the question-and-answer session following presentation of the results, an attendee commented that "it’s a little disturbing that the more frequent dose seemed to be numerically inferior to the less-frequent dose at virtually every measured outcome."

Dr. Sandborn said that the investigators have extensively examined that question and determined that "there’s noise around the measurements, but you couldn’t draw any firm statistical conclusions."

The study was funded by Millennium/Takeda. Dr. Sandborn disclosed serving as a consultant and receiving grant and research support from the combined companies.

I attended an excellent presentation by Hopkins' Leonard Feldman, MD, FAAP, FACP, SFHM, that challenged some of our practices, most notably unnecessary diagnostic tests that cost the hundreds of billions of dollars per year. Dr. Feldman focused on the evaluation of syncope, seizure prophylaxis for brain tumors, adjusting serum potassium levels in STEMI, and GI prophylaxis outside of the ICU.

Here are the key takeways for hospitalists:

• Using carotid Doppler for the evaluation of syncope adds no value in unveiling the etiology. Even if used in a high-risk group with cardiovascular disease, Doppler is helpful in determining the etiology only in the presence of focal neurological symptoms or carotid bruits. On the other hand, checking orthostatics is very helpful and inexpensive, providing an etiology about 25% to 30% of the time.
• There is no benefit of a 7-day peri-operative seizure prophylaxis in patients undergoing resection for a brain tumor (Wu et al, Journal of Neurosurgery, April 2013). The number of seizures within 30 days was actually slightly higher in the group of patients, who had received prophylaxis.

Watch a 2-minute video clip of Bob Wachter's HM13 keynote address

• In the past, medical societies have published guidelines for target serum potassium levels. These had been developed in the setting of STEMI and date back quite a while, before beta-blockers or reperfusion therapies were utilized in the acute management of STEMI. Target potassium levels of >4.0 or even between 4.5 and 5.5 had been recommended. Review of the literature did not find evidence to support this, but rather suggests that a target range of 3.5 to 4.5 is advisable.
• Hospitalized patients are frequently placed on proton-pump inhibitors (PPI) or H2-blockers for GI prophylaxis. Is there any benefit of this practice outside of the ICU? According to a study by Herzig et al (Archives of Internal Medicine, June 2011) clinically significant GI bleeding occurred in 0.18% of patients without prophylaxis compared to 0.26% with prophylaxis. To look at it from a different angle: The number needed to treat to prevent 1 episode of clinically significant GI bleeding was 834, whereas the number needed to harm was 553 for C. diff and 111 for hospital-acquired pneumonia. According to these data, there is no benefit and, if anything, harm done by providing GI prophylaxis to hospitalized patients outside of the ICU.

This is just a small sample of all the things we do. The results should motivate us to look for many other things we may do for no reason in our daily practice. TH

Dr. Suehler is a hospitalist at Mercy Hospital, Allina Health, in Minneapolis, and Team Hospitalist member.

I attended an excellent presentation by Hopkins' Leonard Feldman, MD, FAAP, FACP, SFHM, that challenged some of our practices, most notably unnecessary diagnostic tests that cost the hundreds of billions of dollars per year. Dr. Feldman focused on the evaluation of syncope, seizure prophylaxis for brain tumors, adjusting serum potassium levels in STEMI, and GI prophylaxis outside of the ICU.

Here are the key takeways for hospitalists:

• Using carotid Doppler for the evaluation of syncope adds no value in unveiling the etiology. Even if used in a high-risk group with cardiovascular disease, Doppler is helpful in determining the etiology only in the presence of focal neurological symptoms or carotid bruits. On the other hand, checking orthostatics is very helpful and inexpensive, providing an etiology about 25% to 30% of the time.
• There is no benefit of a 7-day peri-operative seizure prophylaxis in patients undergoing resection for a brain tumor (Wu et al, Journal of Neurosurgery, April 2013). The number of seizures within 30 days was actually slightly higher in the group of patients, who had received prophylaxis.

Watch a 2-minute video clip of Bob Wachter's HM13 keynote address

• In the past, medical societies have published guidelines for target serum potassium levels. These had been developed in the setting of STEMI and date back quite a while, before beta-blockers or reperfusion therapies were utilized in the acute management of STEMI. Target potassium levels of >4.0 or even between 4.5 and 5.5 had been recommended. Review of the literature did not find evidence to support this, but rather suggests that a target range of 3.5 to 4.5 is advisable.
• Hospitalized patients are frequently placed on proton-pump inhibitors (PPI) or H2-blockers for GI prophylaxis. Is there any benefit of this practice outside of the ICU? According to a study by Herzig et al (Archives of Internal Medicine, June 2011) clinically significant GI bleeding occurred in 0.18% of patients without prophylaxis compared to 0.26% with prophylaxis. To look at it from a different angle: The number needed to treat to prevent 1 episode of clinically significant GI bleeding was 834, whereas the number needed to harm was 553 for C. diff and 111 for hospital-acquired pneumonia. According to these data, there is no benefit and, if anything, harm done by providing GI prophylaxis to hospitalized patients outside of the ICU.

This is just a small sample of all the things we do. The results should motivate us to look for many other things we may do for no reason in our daily practice. TH

Dr. Suehler is a hospitalist at Mercy Hospital, Allina Health, in Minneapolis, and Team Hospitalist member.

I attended an excellent presentation by Hopkins' Leonard Feldman, MD, FAAP, FACP, SFHM, that challenged some of our practices, most notably unnecessary diagnostic tests that cost the hundreds of billions of dollars per year. Dr. Feldman focused on the evaluation of syncope, seizure prophylaxis for brain tumors, adjusting serum potassium levels in STEMI, and GI prophylaxis outside of the ICU.

Here are the key takeways for hospitalists:

• Using carotid Doppler for the evaluation of syncope adds no value in unveiling the etiology. Even if used in a high-risk group with cardiovascular disease, Doppler is helpful in determining the etiology only in the presence of focal neurological symptoms or carotid bruits. On the other hand, checking orthostatics is very helpful and inexpensive, providing an etiology about 25% to 30% of the time.
• There is no benefit of a 7-day peri-operative seizure prophylaxis in patients undergoing resection for a brain tumor (Wu et al, Journal of Neurosurgery, April 2013). The number of seizures within 30 days was actually slightly higher in the group of patients, who had received prophylaxis.

Watch a 2-minute video clip of Bob Wachter's HM13 keynote address

• In the past, medical societies have published guidelines for target serum potassium levels. These had been developed in the setting of STEMI and date back quite a while, before beta-blockers or reperfusion therapies were utilized in the acute management of STEMI. Target potassium levels of >4.0 or even between 4.5 and 5.5 had been recommended. Review of the literature did not find evidence to support this, but rather suggests that a target range of 3.5 to 4.5 is advisable.
• Hospitalized patients are frequently placed on proton-pump inhibitors (PPI) or H2-blockers for GI prophylaxis. Is there any benefit of this practice outside of the ICU? According to a study by Herzig et al (Archives of Internal Medicine, June 2011) clinically significant GI bleeding occurred in 0.18% of patients without prophylaxis compared to 0.26% with prophylaxis. To look at it from a different angle: The number needed to treat to prevent 1 episode of clinically significant GI bleeding was 834, whereas the number needed to harm was 553 for C. diff and 111 for hospital-acquired pneumonia. According to these data, there is no benefit and, if anything, harm done by providing GI prophylaxis to hospitalized patients outside of the ICU.

This is just a small sample of all the things we do. The results should motivate us to look for many other things we may do for no reason in our daily practice. TH

Dr. Suehler is a hospitalist at Mercy Hospital, Allina Health, in Minneapolis, and Team Hospitalist member.